Colorectal Cancer
Conditions
Keywords
colon cancer, rectal cancer
Brief summary
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colon cancer. PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema, computed tomographic colonography, and colonoscopy in detecting of colon cancer.
Detailed description
OBJECTIVES: * Compare the accuracy of air contrast barium enema, computed tomographic colonography (virtual colonoscopy), and colonoscopy for the detection of colonic lesions in patients with factors related to colon cancer. * Compare the patient experience during each of these imaging tests. OUTLINE: This is a multicenter study. A repeat fecal occult blood test is performed. Patients then undergo an air contrast barium enema (ACBE). At 7-10 days after ACBE, patients undergo a computed tomographic colonography (virtual colonoscopy) followed by a colonoscopy on the same day. A repeat ACBE may be performed if there is a discrepancy between the initial ACBE and colonoscopy. If the repeat ACBE continues to show an abnormality, patients undergo a second colonoscopy. Within 24 hours of completion of each test, patients fill out a questionnaire about their experience. At 5-7 days after completion of all tests, patients complete a final questionnaire comparing all 3 tests. PROJECTED ACCRUAL: A total of 2,133 patients will be accrued for this study within 4 years.
Interventions
PROCEDUREbarium enema injection
PROCEDUREcomputed tomography
PROCEDUREcomputed tomography colonography
PROCEDUREdiagnostic colonoscopy
PROCEDUREscreening colonoscopy
Sponsors
Duke University
Study design
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * One of the following must be present: * At least 1 positive fecal occult blood test within the past 6 months * Iron deficiency anemia, defined as: * Hemoglobin less than 13 g/dL (males) * Hemoglobin less than 12 g/dL (females) * Ferritin less than 45 g/dL * Episode of bright red blood per the rectum * Family history of colon cancer or adenoma * One first-degree relative diagnosed with colon cancer or adenoma at age 60 or under OR * Two first-degree relatives diagnosed with colon cancer or adenoma at any age * No active gastrointestinal hemorrhage, including any of the following: * Reported or witnessed hematemesis * Melenic stools * Melenemesis * Multiple episodes of hematochezia within the past 2 months PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No myocardial infarction or cerebrovascular accident within the past 6 weeks Pulmonary: * No respiratory failure within the past 6 weeks Other: * No serious medical disorder (e.g., sepsis) within the past 6 weeks * Weight less than 300 pounds * Willing and able to undergo endoscopic or radiologic procedures * No need for special precautions in performing endoscopic procedures (e.g., antibiotic prophylaxis or complicated anticoagulation reversal) * No prisoners * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent clinical trial participation involving drugs, medical devices, and/or biologics
Countries
United States
Outcome results
None listed